Germany refuses to renew GMP cert for Dr Reddy's Bachupally FTO 2 plant
According to a post on the EudraGMDP database, inspectors from the Government of Upper Bavaria - Central Authority for Supervision of Medicinal Products in Bavaria (GMP/GCP) - who visited the site this month identified a number of problems.
The problems range from critical deficiencies related to quality systems used at the site through to major deficiencies linked to Dr Reddy’s failure to log equipment breakdowns, document cleaning procedures or investigate out of spec (OOS) test results.
The Indian drug firm confirmed the news in a Bombay Stock Exchange (BSE) filing today, explaining its subsidiary betapharm Arzneimittel GmbH was notified of the decision by German authorities this week.
Dr Reddy’s said: “The GMP compliance certificate in respect of the Company’s Formulations Manufacturing Unit 2 in Bachupally, Hyderabad is not renewed consequent to thew recent inspection of the plant.”
The Indian firm add that as a result “the plant will not be able to make any further despatch to the European Union until the next inspection, to be initiated by an invitation from betapharm.”
Regulatory issues
The decision comes three months after Dr Reddy’s was issued with a Form 483 detailing 11 problems identified at a neighbouring facility – Plant 3 - by US Food and Drug Administration (FDA) inspectors who visited in Bachupally campus in April.
Three other Dr Reddy’s plants - its active pharmaceutical ingredient (API) facilities in Miryalaguda, Duvvada and Srikakulam – have been issued with Form 483s by the US FDA this year.
